INNOVENT BIO(01801.HK): Tyvyt® Plus Elunate® Approved for Advanced Renal Cell Carcinoma
NewTimeSpace News: Innovent Biologics (01801.HK) announced that the new drug application for the combination therapy of Tyvyt® (Sintilimab Injection) and Elunate® (Fruquintinib) has been approved by the NMPA. It is indicated for locally advanced or metastatic renal cell carcinoma in patients who failed prior VEGFR-TKI treatment and have not received first-line PD-1/PD-L1 inhibitors. This marks the 10th approved indication of Tyvyt®.
NewTimeSpace News: Innovent Biologics (01801.HK) released a voluntary announcement on May 21, 2026, confirming that Tyvyt® combined with Elunate® has obtained NMPA approval for advanced renal cell carcinoma treatment.
The approval is backed by registrational data from the FRUSICA-2 study. As a randomized, open-label, positive-controlled registrational trial, it aimed to evaluate the efficacy and safety of sintilimab plus fruquintinib versus axitinib or everolimus monotherapy as second-line treatment for advanced renal cell carcinoma, and met the primary endpoint of progression-free survival assessed by blinded independent central review.
Phase III findings of FRUSICA-2 were presented at the 2025 ESMO Congress. As of February 17, 2025, the median BICR-assessed progression-free survival reached 22.2 months in the combination group versus 6.9 months in the control group, with a hazard ratio of 0.373. The objective response rates were 60.5% vs 24.3%, and the median duration of response stood at 23.7 months vs 11.3 months respectively.
Therapeutic benefits were observed across all prognostic risk groups stratified per IMDC criteria. The combination regimen showed a favorable safety profile consistent with the known safety features of each agent.
Sintilimab is an innovative PD-1 IgG4 monoclonal antibody co-developed by Innovent and Eli Lilly. Fruquintinib is a selective oral inhibitor targeting VEGFR-1, VEGFR-2 and VEGFR-3.
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